Platelet Rich Plasma and Supraspinatus Tear

Supraspinatus Tear Clinical Trial

Official title:

Efficacy of Platelet Rich Plasma Injection in Comparison to Physical Therapy for Treatment of Chronic Partial Supraspinatus Tears

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03942679
• Other study ID #: MS/17.08.79
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: April 10, 2020

Study information

• Verified date: May 2019
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Rheumatology and Rehabilitation Department, Mansoura University Hospital. Forty patients with chronic partial supraspinatus tears will be included in the study. The diagnosis of the supraspinatus tear will be made by ultrasound examination

Description:

At inclusion in the study, demographic data (age, gender, duration of complaints, and body mass index) will be recorded.

Randomization

Patients will be randomized into two matched groups:

A) PRP-Injection Group - Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.

B) Physical Therapy Group - Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.

Patients in t

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 10, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

chronic partial supraspinatus tears will be included in the study

Exclusion Criteria:

age > 80 years, pregnancy, full thickness supraspinatus tears, other rotator cuff lesions with/without supraspinatus tears, systemic disorders such as diabetes rheumatoid arthritis, hematological diseases (co-agulopathy),

Related Conditions & MeSH terms

• Supraspinatus Tear

Intervention

Other:
• PRP
Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.
• physiotherapy
Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.

Locations

Country	Name	City	State
Egypt	Reham Magdy Shaat	Mansoura	Dakahlia Provence

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change of pain from base line	The VAS-pain score is composed of a continuous horizontal line. This line is 100 mm in length. To measure the intensity of pain, the score is anchored by (0 score = no pain) at one end and (100 score = worst imaginable pain) on the other end. The patient places a mark to the VAS line at the point which represents the intensity of his pain	immediately before injection,6 weeks after injection,12 weeks after injection
Primary	change of range of motion from base line	III. Examination of passive and active range of motion using goniometer based on the description of norkin and white as following; Abduction ;170; Adduction :50; Flexion :165; Extension:60; Internal rotation at 90 abduction :70; External rotation at 90 abduction :100	immediately before injection,6 weeks after injection,12 weeks after injection
Secondary	change of shoulder index score from base line	•Disability and health related quality of life will be measured using DASH shoulder rating scale.	immediately before injection,6 weeks after injection,12 weeks after injection
Secondary	change of ultrasound pathology from base line	•US documented pathology will be assessed at diagnosis and at 12 weeks.	immediately before injection,,12 weeks after injection